The Heartflow Coronary Disease Progression Evaluation Study | NCT04052256

Studies
The Heartflow Coronary Disease Progression Evaluation Study

NCT04052256

Sponsor

Erasmus Medical Center

Status

Unknown status

Last Update Posted

Jul 27, 2022Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Coronary computed tomography angiography

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2018Actual

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 1, 2023Estimated

First Submitted Date

Aug 8, 2019

First Submission Date that Met QC Criteria

Aug 8, 2019

First Posted Date

Aug 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2022

Last Update Posted Date

Jul 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicolas van Mieghem, Director of Interventional Cardiology, Erasmus Medical CenterPrincipal Investigator

Lead Sponsor

Erasmus Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Invasively measured fractional flow reserve (FFR) has proven to be useful in guiding coronary revascularization. Several studies have shown that it is justified to treat lesions with a value of 0.80 or lower and safe to defer from PCI in lesions with a value of >0.80. Recently, computational fluid dynamics have allowed FFR measurement from coronary computed tomography angiography images (FFRCT) with excellent diagnostic accuracy compared to invasive FFR.

FFRCT can also effectively guide revascularization safely deferring patient with FFRCT >0.80 from invasive angiography. In functionally non-significant lesions, computational fluid dynamic models in addition to CT plaque characteristics (low attenuation, positive remodelling, spotty calcification and napkin-ring sign) may be able to predict which lesions will become flow-limiting, causing clinical events in the future.

This study will evaluate disease progression in intermediate lesions (invasive FFR 0.81-0.90 at baseline) using FFRCT at 2 years and determine whether CT characteristics may help to identify lesions that are more susceptible for FFR decline. Additionally, we will correlate CT characteristics with coronary events (a composite endpoint consisting of all-cause mortality, target-vessel myocardial infarction and clinically driven target-vessel revascularization) up to 5 years after the baseline invasive FFR.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with intermediate coronary lesions		Patients (age ≥ 18 years) who have undergone invasive coronary angiography and have a minimum of one non-treated coronary artery with a measured invasive FFR of 0.81-0.90.	Diagnostic Test: Coronary computed tomography angiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coronary computed tomography angiography	Diagnostic Test	Computational fluid dynamic model information derived from CT	Patients with intermediate coronary lesions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coronary atherosclerotic disease progression	FFRCT	2 years

Secondary Outcomes

Measure	Description	Time Frame
Target lesion failure Target vessel failure	Composite of all-cause mortality, target-vessel myocardial infarction and cinically driven target vessel revascularization.	3-5 years
Any coronary revascularisation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients (age ≥ 18 years) treated with PCI (for non-ST elevation myocardial infarction, unstable or stable angina and silent ischemia) or who undergo invasive FFR.
Minimum of one non-treated coronary artery with an intermediate lesion and invasive FFR 0.81-0.90 to serve as the target vessel for FFRCT.

Exclusion Criteria:

ST elevation myocardial infarction.
Previous CABG.
Target vessel for FFR measurement < 2.0 mm in diameter.
Contraindications to contrast agents, beta-blocking agents, nitroglycerin or adenosine.
Life expectancy less than 3 years.
Creatinine clearance < 30 ml/min*1.73m2.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients (age ≥ 18 years) treated with PCI (for non-ST elevation myocardial infarction, unstable or stable angina and silent ischemia) or who undergo invasive FFR.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nicolas van Mieghem, MD, PhD	Contact	00311070438894		n.vanmieghem@erasmusmc.nl
Admir Dedic, MD, PhD	Contact	00311070438894		a.dedic@erasmusmc.nl

Overall Officials

Name	Affiliation	Role
Jonathan A Leipsic, MD, PhD	University of British Columbia	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmus MC	Recruiting	Rotterdam			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

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Browse Branches

Not provided